A Pilot Study of Needle Size and Pain Perception With Botulinum Toxin A Injections

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01981174
First received: November 5, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to compare the levels of pain resulting from injections of Botox® for wrinkles on the forehead and between the eyes using two different sized needles (32 gauge and 30 gauge needles).


Condition Intervention
Pain
Procedure: 30-gauge needle
Procedure: 32-gauge needle

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: The Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin A Injections

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Visual analog score (VAS) pain rating after each side is injected [ Time Frame: 1 hour on Treatment day ] [ Designated as safety issue: No ]
    Subjects will rate pain using the visual analog score (VAS 1-10) after each side is injected using the 30 or 32 gauge needles. Lower values represents less pain; higher values represents more pain.


Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 30-gauge needle
Subjects will be screened, assessed, and randomized to be injected with onabotulinum toxin A using a 30-gauge needle on one side of the face and injected using a 32-gauge needle on the other side during their first clinic visit. All needles would be luer lock, ½ inch length, and attached to separate 1cc syringes. Injection depth would be 1-2mm, dermal, and the angle of incidence would be perpendicular.
Procedure: 30-gauge needle
Active Comparator: 32-gauge needle
Subjects will be screened, assessed, and randomized to be injected with onabotulinum toxin A using a 30-gauge needle on one side of the face and injected using a 32-gauge needle on the other side during their first clinic visit. All needles would be luer lock, ½ inch length, and attached to separate 1cc syringes. Injection depth would be 1-2mm, dermal, and the angle of incidence would be perpendicular.
Procedure: 32-gauge needle

Detailed Description:

Subjects will be screened, assessed, and randomized to be injected with onabotulinum toxin A using a 30-gauge needle on one side of the face and injected using a 32-gauge needle on the other side during their first clinic visit. This study is a pilot study designed to determine feasibility of these procedures.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. In good health
  2. Is a female
  3. Is 25-70 years of age
  4. Has moderate dynamic forehead/glabellar wrinkles
  5. Has willingness and the ability to understand and provide informed consent and communicate with the study staff

Exclusion Criteria:

  1. Younger than 25 or older than 70 years of age
  2. Pregnant or lactating
  3. Is a male
  4. Has received the following treatments in the forehead or glabellar region:

    1. botulinum toxin injections in the past 6 months
    2. ablative laser procedure in the past 6 months
    3. radiofrequency device treatment in the past 6 months
    4. ultrasound device treatment in the past 6 months
    5. medium to deep chemical peel in the past 6 months
    6. temporary soft tissue augmentation material in the area to be treated in the past year
    7. semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
    8. permanent soft tissue augmentation material in the area to be treated
  5. Has an active infection in the forehead or glabellar region (excluding mild acne)
  6. Is allergic to cow's-milk protein
  7. Is allergic to albumin
  8. Taking aminoglycoside
  9. Is currently using anticoagulation therapy
  10. Has a history of bleeding disorders
  11. Has a mental illness
  12. Unable to understand the protocol or to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01981174

Locations
United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT01981174     History of Changes
Other Study ID Numbers: STU84470
Study First Received: November 5, 2013
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014